MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CLOSUREFAST PROCEDURE PACK-LF

Catalog Number	DYNJ0365463J
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6), the medical assistant was filling up the 10cc syringe from the cfp pack with lidocaine and noticed a leak from a long crack in the body of the syringe as she pushed the air out of the syringe.The device was not used on the patient.
Additional Manufacturer Narrative
According to the facility on (b)(6), the medical assistant was filling up the 10cc syringe from the cfp pack with lidocaine and noticed a leak from a long crack in the body of the syringe as she pushed the air out of the syringe.The device was not used on the patient.Another 10cc syringe from a replacement cfp procedure pack was used to complete the procedure.There was no patient involvement.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn: 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: CLOSUREFAST PROCEDURE PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20846193
• Report Number: 1423395-2024-00508
• Device Sequence Number: 3758084
• Product Code: FDE
• UDI-Device Identifier: 40193489783873
• UDI-Public: 40193489783873
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: DYNJ0365463J
• Device Lot Number: 24CMH288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown